Senior Quality Engineer: Process & PIR Leader

Boston Scientific Gruppe; Arden Hills (MN); Hybrid; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific in Arden Hills, Minnesota, is seeking a Senior Quality Engineer to lead and coordinate quality investigations, drive root cause analysis, and implement corrective actions while mentoring engineers to improve product quality and regulatory compliance.

The role requires a Bachelor's degree in an engineering discipline, at least five years in a regulated environment, and on-site work five days per week. Travel, sponsorship, and relocation are not offered.

Qualifications

• Bachelor's degree in an engineering discipline or related technical field.
• Minimum of 5 years' experience in a relevant field.
• Experience in a regulated industry.
• Knowledge of and ability to use problem-solving tools to investigate root causes and implement effective solutions.

Responsibilities

• Coordinate Product Inquiry Reports (PIRs) for Arden Hills operations to investigate quality issues and drive decisions on corrective actions.
• Serve as the Arden Hills operations process owner for the PIR process, providing guidance and mentorship across the site.
• Identify and lead projects to improve quality outcomes by reducing manufacturing defects and partnering cross-functionally to drive product improvements.
• Provide technical mentorship to engineers on problem-solving and risk-based decision-making.
• Serve as a subject matter expert in the front room during audits with external bodies.
• Evaluate the adequacy and compliance of systems, operations and practices against applicable regulations and company documentation.
• Apply an understanding of external regulations to drive decision-making and technical solutions.
• Create quality tools and training materials by applying technical expertise and communicating effectively with respective teams.
• Perform appropriate analyses to identify trends, improvement opportunities and corrective actions.

Skills

Root cause analysis

Problem solving

Mentorship

Regulated industry experience

Team collaboration

Education

Bachelor's degree in engineering or related field

Tools

PIR system experience

CAPA software

Audit management tools

Job description

Boston Scientific in Arden Hills, Minnesota, is seeking a Senior Quality Engineer to lead and coordinate quality investigations, drive root cause analysis, and implement corrective actions while mentoring engineers to improve product quality and regulatory compliance.

The role requires a Bachelor's degree in an engineering discipline, at least five years in a regulated environment, and on-site work five days per week. Travel, sponsorship, and relocation are not offered.